Nuffield Orthopaedic Centre NHS Trust and
Oxfordshire Primary Care Trusts
Shared Care Protocol and Information for GPs
Sub-cutaneous methotrexate
This leaflet provides the necessary information and guidance for the shared care of adult patients requiring
subcutaneous methotrexate therapy and should be read in conjunction with the shared care agreement
between Oxfordshire and Berkshire Primary Care Trusts and the Rheumatology Department.
Introduction
Methotrexate is recognised as the most effective of the traditional (non–biologic) disease modifying antirheumatic drugs ( DMARD’s) in current use for rheumatoid arthritis and related conditions. The optimum
therapeutic dose of methotrexate should be achieved to minimise disease progression and joint erosions.
Parenteral methotrexate can:
 Ensure the maximum bioavailability
 Reduce symptomatic side effects for some patients, thus increases in the therapeutic dose are
better tolerated
 Extend the time that disease is controlled before expensive anti-TNF therapies need to be
introduced. BSR guidelines (2003) state that whenever possible patients should have received
methotrexate at a target dose of at least 20mg per week before anti- TNF treatment is considered.
 Improve the patients quality of life and satisfaction with treatment
Dose and administration
 It is usually self administered in a range of 10-25 mg per week. Folic Acid supplementation is
recommended at a dose of 5mg p.o per week, to be given 3-4 days after the methotrexate is
prescribed.
Supply - Methotrexate is supplied in named pre-filled syringes. APCO recommend supply of prefilled syringes of 50 mg/ml as Metoject© (Licensed).
As agreed by APCO only Metoject® subcutaneous methotrexate preparations should be used
within Oxfordshire. All prescribing of methotrexate subcutaneous should be via brand name.
Disposal of Sharps. Cytotoxic sharps boxes need to be supplied. The initial cytotoxic
pharmaceutical waste (sharps) disposal box will be provided by the Clinical Nurse Specialist in
Rheumatology at initiation of treatment, when teaching the patient. Once full this should be
returned sealed (for exchanging with an empty replacement white rose environmental cytotoxic
pharmaceutical waste disposal box) preferably to the patients GP practice or in exceptional prearranged circumstances and only as part of a planned follow up clinical appointment to the
rheumatology out patient department. Patients are advised to return their boxes for disposal and
replacement when full or approximately every 3-6 months.
Adverse effects. As for oral Methotrexate
Please note that in addition to absolute values for heamatological indices a rapid fall or a consistent
downward trend in any value should prompt caution and extra vigilance.
Written by M Cox / Verified by P Bowness. Version 8. (May 2011) Approved by APCO.
For review Nov 2012
© Nuffield Orthopaedic Centre
1
Nausea
Mouth ulcers
Rash or severe oral ulceration
Progressive fall in WBC
< 3.5 X 10^9/l
WBC < 4 X 10 ^9 /l
Ensure pt is on Folic acid, consider increase of Folic acid
as noted below.
Anti emetic can be prescribed
May respond to an increase in Folic Acid, 5mg, 3 days a
week, which can be increased to 5mg, 6 days a week if
necessary (omitted on day Methotrexate is taken)
With hold until discussed with rheumatologist. Look for
alternative causes. Re-challenge with lower dose once
symptoms settle.
Perform a differential and increase frequency of
monitoring
Neutrophils <2 X10^9/l
Withhold, repeat WBC, if normal continue, otherwise
discuss with rheumatologist
Withhold until discussed with rheumatologist
Platelets <150 X10^9/l
Withhold until discussed with rheumatologist
Liver function. >2 fold rise in ALT
from upper limit of reference
range
Withhold until discussed with rheumatologist.
Transaminase increase 2 X normal is common within 2
days of drug administration. Consider rechecking ALT at
trough level. (i.e 0-2 days prior to injection)
Reduce dose by 50%
Increase frequency of monitoring
Renal Impairment. i.e
<30 mls minute
eGFR
MCV > 105 fl
Unexplained fall in Albumin
New or increased dyspnoea, or
dry cough
Significant reduction in renal
function
Alopecia
Menstural dysfunction /
Amenorrhoea
Check folate. GGT, TSH B12. If B12 or folate low, start
appropriate supplementation.
Withhold until discussed with rheumatologist
? Pneumonitis particularly if accompanied by fever or
night sweats. Withhold and refer to rheumatologist
urgently
? alternative causes, reduce dose following discussion
with rheumatologist..
Increase in hairfall is common, baldness is rare.
May occur during treatment and for a short time following
cessation.
Notes:
 One weekly dose of Methotrexate can be withheld without inducing a flare.
 Methotrexate should not be stopped prior to elective surgery.
 Pneumovax and annual flu vaccinations are recommended.
Contra Indications and Precautions
Problem
Pregnancy and breastfeeding
Vaccination with live vaccines
Chronic diver disease / Alcoholism
Risk
For men and women, contraceptive advice
should be given, as pregnancy should be
prevented for a minimum of 4 months after
discontinuation of treatment. Breast feeding
should be avoided.
Severe antigenic reaction. Possible reduced
immunological response to inactivated
vaccines
Alcohol can cause potential liver damage
Written by M Cox / Verified by P Bowness. Version 8. (May 2011) Approved by APCO.
For review Nov 2012
© Nuffield Orthopaedic Centre
2
Chicken pox /Shingles
Viral respiratory infections
therefore alcohol should only be taken in
moderation.
Patients suffering from chicken pox. Withhold
Methotrexate. Recent exposure (patients who
have not had chickenpox) inform
rheumatologist.
Shingles – Active skin lesions, with hold
Methotrexate and inform rheumatologist.
Treat infection as appropriate give
methotrexate unless symptoms significant.
Drug interactions (refer also to BNF or SPC)
NSAID’s in addition to the recommended doses of Methotrexate are not contraindicated.
Concomitant use of other drugs with anti-folate activities i.e. Cotrimoxazole and Trimethoprim should be
avoided.
Monitoring
Pre treatment assessment by Rheumatologist
FBC, ESR, CRP, LFT’s and U&E’s will be checked prior to commencement.
A baseline chest X-Ray. Lung Function tests may be requested in patients with risk factors or pre-existing
lung conditions.
Monitoring by GP
FBC, ESR, CRP and LFT’s, U& E’s every two weeks for three months, then monthly. If possible blood tests
should be taken at the trough level, i.e. on the morning before taking the Methotrexate.
If the patient’s condition is stable the frequency of monitoring may be extended to 6 weekly at 6 months
Blood results should be recorded in the shared care card.
If a second DMARD is introduced as a combination, then the frequency of monitoring should be increased to
the initial starting levels.
Patient information leaflet
Patients should be supplied with an information leaflet from the manufacturer.
Shared Care Responsibilities
Shared care assumes communication between the specialist, GP and patient. The intention to share care
should be explained to the patient and accepted by them. Patients should be under regular follow-up which
provides an opportunity to discuss drug therapy.
a)
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Rheumatology Consultant
Pre treatment assessment and recommendation of the appropriate DMARD to be prescribed.
Write to the GP requesting shared care and outline shared care protocol criteria.
Pre treatment counselling to include rationale for treatment, benefits, potential side effects,
precautions and monitoring requirements ensuring patients understand their role in reporting
adverse effects promptly.
Teaching package provided by rheumatology Clinical Nurse Specialist re self administration of
methotrexate.
Issue written patient drug information, shared care monitoring booklet, contact telephone number.
Ensure clinical supervision of the patient is done by follow-up as appropriate.
Liaise with GP regarding changes in disease management, drug dose, missed clinic appointments.
Provide telephone / email support in the event of any serious adverse reactions by a member of the
medical team.
Additional support for patients and members of the primary care team, via the rheumatology
telephone Advice-line.
Written by M Cox / Verified by P Bowness. Version 8. (May 2011) Approved by APCO.
For review Nov 2012
© Nuffield Orthopaedic Centre
3
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Provision of formal or informal training as necessary to ensure that clinical staff within the primary
care team have the necessary skills to ensure safe practice.
b) General Practitioner
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Prescribing the S/C methotrexate once the dose is stable as per recommendation of consultant
Provision of services related to the shared care agreement as listed in the GMS contract, in respect
of near patient testing. Ensuring blood tests are taken in accordance with the rheumatology unit
information sheets and National Guidelines for the monitoring of second line drugs (BSR 2000)
Monitor for adverse effects as detailed above.
Checking and recording of blood test results.
Advise the consultant rheumatologist of any changes in the patient’s condition, any adverse drug
reactions, or if the patient fails to attend for blood monitoring.
Ensuring that all clinical staff involved in the provision of this service have the relevant knowledge
and skills.
c) The patient
 Attending for blood monitoring
 Ensuring shared care card is kept up to date
 Reporting any adverse side effects to medication to the GP or a member of the hospital
rheumatology team.
 Ensuring that they bring the shared care card and a list of all medications to the surgery and out
patient consultations.
Contact Numbers
Nuffield Orthopaedic Centre. Rheumatology
Registrar on call
01865 741155
Bleep Rheumatology Registrar on call
Rheumatology Advice line (Answer phone)
01865 737656
Rheumatology practitioners
01865 737657
Copies of all these sheets are available for general use by GP’s via the unit or electronically on
the NOC website or the PCT Intranet (nww.oxfordshirepct.nhs.uk under General Practice /
Prescribing and Medicines Management / Shared Care Protocols)
Written by M Cox / Verified by P Bowness. Version 8. (May 2011) Approved by APCO.
For review Nov 2012
© Nuffield Orthopaedic Centre
4
Procedure for Supply of S/C Methotrexate
Consultant decision to change to S/c
Methotrexate
Normal Clinic Letter
to GP advising of
suggested change
Letter to CNS
requesting training
for patient in S/C
injection technique
Letter to GP from
CNS confirming
training taken place
and including
specifics of
prescription required
Patient attends CNS
appointment for
training
GP supplies
prescription and
organises
appropriate sharps
box with PCT
Patient contacts CNS when
supplies and sharps box
obtained. Attends CNS
clinic to administer
injection(s) under
supervision until confident
re self administration
Ongoing advice and support available to patient and
members of the primary care team via telephone
advice line
Written by M Cox / Verified by P Bowness. Version 8. (May 2011) Approved by APCO.
For review Nov 2012
© Nuffield Orthopaedic Centre
5